Risk Occurence

Project Description

The quality standards of medical devices contain many aspects such as design control, Risk management, vendor management etc. In this paper we are going to discuss the importance of Risk management for medical devices and steps to perform during the product development stage. Risk management is a critical part of the medical device product development lifecycle. It helps medical device developers ensure that the product is reliable, works as expected and will be no harm to the patients, operators or the environment. In other words, the main purpose of the Risk management cycle is to reduce or subdue the chances of failure in the product.

Medical Needs is a company that designs and manufactures medical devices and will be opening a new company and would like for us to do the risk management involved with the materials used for these devices and the design to ensure the devices are compliant to all regulations during production. There are many areas we will cover during this project to ensure that a quality product is available for the public consumer. We are looking at completing this project in less than six months before the manufacturing process commences.

. We will be using an Agile Method to conduct this risk assessment. The agile approach with more checkpoints, lets you refine what you are building for the customer, and what they are ultimately provided in the end user. Agile provides the opportunity to take what you created, give it to a client, and evoke feedback. Based on the feedback, you can determine whether you are going in the right direction. If changes are required, you give yourself the opportunity to adapt and adjust.

When developing medical devices, many inputs that must be taken into consideration. Identify the needs of the end user but understand the potential risks that the product may present to end users and ensure that your product is sufficiently safe and effective by designing risk modification into your medical device. When using the agile process, you must understand how the Risk management process fits in, and then consolidate that approach into the project development plan.

Overall Risk Management Strategy

The strategy being used for risk management will involve four different steps:

Risk Analysis: Analytical use of available information to realize hazards and estimate a risk. Risk Estimation: Process used to assign values to the probability of incident and severity of harm. Risk Assessment: Overall process involving a risk analysis and risk evaluation. Risk Evaluation: Process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk. These four methods will be combined to create a competent risk management strategy. During every step, the company representatives and myself will be weekly to discuss how to proceed with the specific areas to perform analysis and estimations in order to come up with the Risk Evaluation.

In order to comply with the ISO 14971 standards. at the beginning of each design project a design plan is created. The design plan should include a risk management plan section, or a separate risk management plan shall be created. The risk management plan only needs to cover from the beginning of the project to product release–not post-market risk activities. The risk management plan during the design phase shall include at least the following elements:

Medical device-related deaths and serious injuries: What serious adverse events related to this medical device were known when FDA authorized the device for marketing? Were there any variations in serious adverse events among subpopulations.

Likelihood of Risk: How frequently does this specific failure mode or defect occur? Has the rate of medical device failures increased? Has the mean time between failures decreased? How many medical devices are expected to have a problem? What proportion of patients treated with or diagnosed by the nonconforming medical device is harmed? How many patients were exposed to nonconforming devices? How many patients were exposed to a device manufactured by a noncompliant manufacturer?

Risk Factors for healthcare professionals or caregivers: Are there any changes in frequency or severity of risks for healthcare professionals and/or caregivers? Do any changes in the frequency or severity of risk for the healthcare provider or caregiver impact the risks to the patient?

List the risks in the Risk Register, provide detailed descriptions of the risks, and discuss the potential impacts on the project if the risk events occur.

Perform a qualitative risk analysis on the risks, and determine the priority of the risks using the probability and impact matrix.

Perform a quantitative risk analysis on the risks that have been prioritized, and complete the quantitative risk analysis results matrix.

Describe the risk response strategies for each of your risks.

Discuss your plan for reviewing the risk responses.

Discuss the plan for identifying new risks in your project.

Complete the communications matrix for discussing risk elements with your stakeholders.

Write a memo to the project sponsor describing the risk approach, the appropriateness of the risk identification process, an overview of the risk analyses activities, the responses strategies you did not use, and improvement ideas.

Project Management Institute. (2009). Practice standard for project risk management. [Vitalsource version]. Retrieved from https://online.vitalsource.com/#/books/9781933890388/cfi/0!/4/[email protected]:0.00

Project Management Institute, A guide to the project management body of knowledge (PMBOK® guide), Fifth Edition, Project Management Institute Inc. 2013. [Vitalsource version]. Retrieved from https://online.vitalsource.com/#/books/9781935589815/cfi/0